About trials in New Zealand
Why conduct a clinical trial in New Zealand?
Welcome. If you are new to our country, the first thing you should know is that we are a place of innovation, straight talking and entrepreneurial advancement. New Zealand offers a world class track record with early phase and proof of concept trials and independent, clean and accurate clinical data.
Does New Zealand follow Good Clinical Practice Guidelines?
Yes, Good Clinical Research Practice guidelines based on ICH-GCP have been followed in New Zealand since 1996. New Zealand-specific GCRP Guidelines have been available since 1998.
Is the Regulatory Environment Straightforward?
Yes, Health & Disability Ethics Committee (HDEC) approval is required for all research involving humans. Only one ethics committee review is required per study in New Zealand and covers all sites. It takes 4-6 weeks from submission to full approval. The process is not difficult, but it's important to know the documents to prepare, the groups to be contacted and the processes to follow.
Does a clinical trial conducted in New Zealand need a sponsor?
Yes. An application for a clinical trial of a medicine (whether approved for distribution in New Zealand or not) must be lodged by, or in the name of a person or company resident in New Zealand.
How is the study medication imported?
Ministry of Health (Medsafe) approval is required for the trial before drugs can be imported into New Zealand. The Medsafe (SCOTT) approval letter states that it may be used as evidence of import approval if required. An import licence is not required. Export approval is not required for investigational product shipped from the U.S to New Zealand.
What about medical device trials?
Medical device developers looking for a rapid, cost effective means of gaining early proof of concept for their products should consider conducting their initial clinical trials in New Zealand. The simple, one ethical committee, approval process here does not require U.S FDA Investigational Device Exemption (IDE) filing prior to the start of the study.
What about Clinical Recruitment & Retention Rates?
New Zealand was the first country in the world to establish an electronic Population Health Index, a system that features a comprehensive database containing nearly 20 years of health encounters and is now supplemented by an equally comprehensive Health Practitioner Index.
Are there National Indemnity and Clinical Trial Agreements?
Yes. After extensive consultation with medical professionals, private and international industry partners, the New Zealand Association of Clinical Research (NZACRES) has developed standard agreements for both Clinical Trial Research and Indemnity and Compensation.
How long does regulatory approval take and what does it cost?
The Ministry of Health's (Medsafe) Standing Committee On Therapeutic Trials (SCOTT) approval process takes a maximum of 45 days, usually less. This is required for non-registered drug formulations, but not for medical devices, nor new indications of NZ registered formulations.